What criteria do you use to determine whether something qualifies as a “new shortage?”
A drug product shortage is defined as a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent. (From ASHP’s Guidelines on Managing Drug Shortages [PDF])
What criteria determine when a shortage is “resolved?”
A drug shortage is considered resolved when all suppliers either have all products back in stock, or have discontinued those products. For this reason, products remain on the shortage list, despite intermittent or partially restored availability. Examples include:
- products on allocation
- products with distribution restrictions(for example, through a special program like Doxil® C.A.R.E.S.)
- products not available in the desired form, e.g., epinephrine in vials, but not syringes; heparin in vials, but not pre-mixed infusions;
- products in shortage for which imported alternatives are temporarily available
What is the “Drugs No Longer Available” list?
The drugs appearing in the Drugs No Longer Available list have been discontinued and are no longer available in the U.S. In most cases, the reason for their unavailability will be detailed in the “Reason for Shortage” section of the shortage monograph.
What is the “No Commercially Available Drug Preparations” list?
The products appearing on this list are in severe shortage and have no presentations available at all from any manufacturer. Products on allocation or available through special programs are not included in this list.
Can I search for a brand name?
Yes, brand names are searchable. Although ASHP lists products in shortage by generic name, brand names are listed in shortage monographs under both the “Products Affected” and “Available Products” sections. However, because brand name is not a standardized field in the drug shortages database, searching by brand name will not give you comprehensive results.
How can I tell when a shortage first began or how long it has been going on?
The date a new shortage is first posted and dates of subsequent updates are listed in reverse chronological order in the “Updated” section of a shortage monograph. Therefore the last date listed is the date the shortage began. For resolved shortages, the date listed in brackets under the drug name is the date the shortage was moved to the resolved list.
Shortages tend to be episodic, however, and a new monograph is generated each time a previously resolved shortage occurs again. The “updated” dates will only show the history of the immediate shortage period, not previous shortage periods.
Can I get new drug shortage information delivered to me?
ASHP offers a Really Simple Syndication (RSS) feed for each shortage list (Current Shortages, Discontinued Drugs, No Commercially Available Preparations and Resolved Shortages). You can subscribe to the Drug Shortages Drug Database Licensing.
Why are some sections in the shortage monographs highlighted in yellow?
Each time a monograph is updated, new information is highlighted in yellow.
Why does ASHP’s drug shortage site have different products in shortage than the FDA’s drug shortage site?
ASHP lists every drug shortage reported through our online report form as soon as it is investigated and confirmed, usually within 24-72 hours. The FDA site focuses only on shortages of medically necessary* drugs, as these have the potential to impact public health. More information is available on FDA’s website.
*A medically necessary drug is a product that prevents a serious disease or medical condition and for which there is no drug or alternative drug, available in adequate quantity that is judged by FDA’s medical staff to be an acceptable substitute. The FDA Drug Shortage Program Staff designates some drugs as medically necessary when the preferred therapy is in shortage.
Why is it necessary to have two websites?
In addition to listing more drugs, ASHP provides practitioner-focused resources to help the healthcare community manage shortages. Examples include information on unapproved drugs and unlabeled uses (when well-researched and reported to be safe and effective); recommendations for therapeutic alternatives; drug to drug comparisons and comparisons within individual drug classes; and safety recommendations.
While the FDA website lists all medically necessary drugs in shortage, regardless of approval status, providing recommendations for practice or information beyond that in the FDA-approved product labeling is outside FDA’s purview.
What does “on allocation” mean?
A product on allocation is one that is distributed in a manner that limits distribution of scarce supplies until a shortage is resolved. Allocation plans may include strategies to control the quantity and frequency of product releases, placing limitations on quantities sold or limiting release to emergency-only use to conserve product for patients with life-threatening conditions for which there is no alternative therapy.
Does ASHP have information on where I can find a supply of a shortage drug?
No. ASHP is a membership organization for hospital and health-system pharmacists. We do not receive, store, or distribute medications. We do not have information on the location of available supplies other that that listed in our shortage monographs under “Available Products” and “Estimated Resupply Dates.”
There is incorrect or confusing information in a shortage monograph. How can I submit a question or a correction?
To report any error or outdated information in a drug shortage monograph, please use the online drug shortage report form. Questions about monographs or other drug shortage issues can also be submitted in this manner. ASHP staff and our partners, the Drug Information Specialists at the University of Utah, will respond and post any needed corrections or additional information within 72 hours.
What is ASHP doing to combat drug shortages?
ASHP has been working to help practitioners and patients deal with drug shortages for over a decade. Since ASHP’s successful advocacy effort to get the Food and Drug Administration Safety and Innovation Act of 2012 [PDF] passed, ASHP members and staff continue to work with the FDA, House and Senate committees, the Government Accountability Office, and other stakeholders on implementation of the Act and to explore causes and solutions for drug shortages. In addition, ASHP is continuing to collect information on the status and impact of drug shortages through several planned surveys with partner healthcare organizations and universities. Results of these surveys will be used to keep the issue front and center with policy makers and other stakeholders. ASHP continues to maintain the Drug Shortages Resource Center and works closely with the FDA to make timely, comprehensive, and useful information available to practitioners and patients. ASHP recently offered several educational sessions at its Midyear Clinical Meeting that addressed drug shortages, and will continue to create and offer educational content in a variety of formats to help healthcare practitioners minimize the effects of drug shortages on patient care.
